Acute Ischemic Stroke MedDRA version: 8.1 Level: LLT Classification code 10055221 Term: Ischemic stroke
Conditions
Interventions
Product Name: MRX-801
Product Code: MRX-801
Pharmaceutical Form: Solution for infusion
CAS Number: 76-19-7
Other descriptive name: OCTAFLUOROPROPANE
Concentration unit: mg/ml milligram(s)/millilitre
C
Sponsors
ImaRx Therapeutics, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet all of the following inclusion criteria to be eligible for enrollment into the trial: 1. Males or females 18 years of age or older. 2. Patients with a diagnosis of intracranial arterial occlusion of the middle cerebral artery (MCA), anterior cerebral artery (ACA), internal carotid artery (ICA), posterior cerebral artery (PCA), or distal basilar artery as demonstrated by US. 3. Patients with neurological deficit measurable by NIHSS score, and that in the opinion of the treating physician requires treatment with full dose IV tPA. 4. Patients with persisting arterial occlusion and without frank resolution of neurological symptoms at the time of diagnostic ultrasound imaging, who, in accordance with local and federal guidelines for use, are eligible for intravenous tPA or have been receiving intravenous tPA for up to 45 minutes 5. Provision of informed consent as demonstrated by the patient’s signature or by the signature of the patient’s authorized legal representative on the Informed Consent Form in accordance with all local and federal regulations. 6. Co-signature on the Informed Consent Form by a qualified member of the study staff signifying that, in his/her professional opinion, informed consent has been obtained in accordance with all local and federal regulations. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients presenting with any of the following will not be included in the trial: 1. Evidence of hemorrhage on non-contrast head CT or MRI scan; 2. Patients with primary intra-arterial thrombolysis. 3. Patients with known right-to-left cardiac shunts as determined from medical history or patient chart. 4. Patients with any known hypersensitivity to the test article or any other diagnostic agents or therapeutics to be used. 5. Patients without temporal insonation windows. 6. Female and pregnant or breast feeding. 7. Patients receiving other investigational drugs, procedures, or therapies within 30 days prior to study treatment. 8. Patients with any standard contraindication for intravenous tPA therapy. 9. Patients with moderate to severe COPD (baseline O2 saturation less than 80% on room air); 10. Significant concurrent medical/neurological conditions or deviation from normal laboratory test values at baseline that, in the opinion of the investigator, pose significant risk to the patient and warrant exclusion from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to provide information regarding the safety, tolerability, and activity in promoting recanalization (at 90 minutes) of escalating doses of MRX-801 accompanied by continuous ultrasound (US) in conjunction with intravenous tPA in subjects with acute ischemic stroke.;Secondary Objective: The secondary objective of this study is to provide preliminary data on longer term outcomes for subjects receiving treatment with MRX-801/US/tPA in comparison with controls receiving current standard of care treatment with tPA alone. Rates of clinical recovery will be determined at 2 hours, 24-36 hours, and 3 months post-treatment using accepted measures of neurological status and overall disability and handicap (National Institutes of Health Stroke Scale (NIHSS) score and modified Rankin scale (mRS) scores, respectively).;Primary end point(s): The primary safety endpoint is a comparison of MRX-801/US and tPA with standard of care tPA treatment (control group) for proportions of subjects experiencing symptomatic intracranial hemorrhage (sICH) within 36 hours of treatment. The primary activity endpoint will be assessed from 0 to 120 minutes from initiation of study treatment as follows: • Proportion of subjects achieving partial or complete recanalization at 120 minutes; • Proportion of subjects achieving any partial or complete recanalization within 120 minutes from initiation of treatment; • Time to complete recanalization. | — |
Countries
Germany
Outcome results
None listed